The Board of Pharmacy would like to provide the following information about its rules relating to the distribution of COVID-19 testing kits, including serology tests, into the state of Iowa. Diagnostic testing kits, such as those used to detect the presence of the novel coronavirus which causes Coronavirus Disease 2019 (COVID-19) in a respiratory sample and those used to detect the presence of antibodies to the virus in a blood sample, are considered medical devices.
The distribution of medical devices exclusively to a health care practitioner for use in the normal course of professional practice (“professional use”) is identified as an activity for which a distributor may, but is not required to, obtain a limited distributor license. See 657 IAC 42.3(2).
A distributor which intends to limit its activity in Iowa to the distribution of medical devices, such as those for COVID-19 testing, for professional use is not required to first obtain a wholesale distributor or limited distributor license. A distributor may obtain a limited distributor license, but is not required to do so prior to engaging in this activity.
This statement should not be interpreted as an endorsement or assurance of quality for any COVID-19 testing kits currently available in the marketplace. Practitioners should review information published by FDA regarding Emergency Use Authorizations and FAQs on Diagnostic Testing for SARS-CoV-2.